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Unipolar Microplasma Radiofrequency Device: In-vivo Histologic Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04153071
Recruitment Status : Withdrawn (Per Investigator and sponsor decision)
First Posted : November 6, 2019
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Alma Lasers

Brief Summary:

Prospective, Open-Label, Single-Center Pilot Study.

The study is aimed to evaluate the histologic effects of a unipolar microplasma electrode pin radiofrequency device (Alma Lasers OPUS system) on the abdominal skin.

The study will include up to 2 subjects. Each subject will have a single cutaneous treatment of their lower abdomen, with variable treatment parameters. Punch biopsies will be obtained from each treatment section, for in-vivo histological evaluations.


Condition or disease Intervention/treatment Phase
Skin Resurfacing Device: OPUS system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Cutaneous Effects of a Unipolar Microplasma Electrode Pin Radiofrequency Device: An In-vivo Histologic Study
Actual Study Start Date : October 23, 2019
Actual Primary Completion Date : September 16, 2020
Actual Study Completion Date : September 16, 2020

Arm Intervention/treatment
Experimental: Unipolar microplasma RF treatment
Single cutaneous unipolar microplasma RF treatment, with variable treatment parameters
Device: OPUS system
Each subject will have a single cutaneous treatment of their lower abdomen, with variable treatment parameters. Punch biopsies will be obtained from each treatment section, for in-vivo histological evaluations.




Primary Outcome Measures :
  1. Diameter and depth of ablation and/or coagulation from varying RF device treatment parameters [ Time Frame: Immediately post treatment ]
    Histology analysis to evaluate the diameter and depth of ablation and/or coagulation from varying microplasma RF device treatment parameters, based on biopsy specimens


Secondary Outcome Measures :
  1. Rate of adverse events [ Time Frame: 10 days ]
    Safety will be monitored by documentation of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject seeking surgical correction of abdominal tissue laxity with an abdominoplasty within the subsequent 1-12 months.
  2. Subject abdominal skin must be of appropriate quality to allow for proper study treatment, as judged by the Investigator.
  3. The subject must be willing to have punch biopsy specimens obtained from all treated areas following treatment.
  4. The Subject must sign a statement of informed consent to the Investigator and Sponsor.

Exclusion Criteria:

  1. The subject is less than 18 or greater than 75 years of age.
  2. Subject with excessive superficial skin laxity and/or striae of the abdomen, which would prevent proper study treatment.
  3. A subject that is unwilling to have punch biopsy specimens obtained from treated areas.
  4. Subject with a history of allergy to lidocaine or epinephrine.
  5. Known history of keloids or bleeding/coagulation disorder.
  6. Presence of surgical or non-surgical scars in the area to be treated.
  7. Active inflammatory or infectious process or any other active or serious skin disease in the area to be treated.
  8. Planned surgical procedures with incisions and suturing in the area to be treated during the course of the study.
  9. Subjects who have had (or plan to have during the course of the study) an abdominal skin treatment with any exclusionary treatments, medications, and/ or devices.
  10. Subjects who have used oral isotretinoin or other oral retinoids during the study in the prior 12 months or planning to be on them during the course of the study.
  11. Subjects receiving antiplatelet, anticoagulant, or non-steroidal anti-inflammatory agents within 2 weeks of treatment, or planning to receive during the course of the study; in whom, in the Investigator's opinion, administration of radiofrequency treatment may cause procedure-related complications.
  12. Women who are pregnant, nursing or intend to become pregnant over the duration of the study, or women who are of childbearing potential not protected by an effective contraceptive method of birth control. Pregnancy status should be checked by urine testing at baseline (Day 0).
  13. Subjects who are unwilling or unable to give written consent to participate in the study or unable to comply with the requirements of the clinical trial protocol.
  14. Subjects who have received an experimental drug or device within the previous 3 months prior to enrollment.
  15. Subjects who are known as alcohol or drug abusers.
  16. Subjects who are suffering from any physical or psychological condition, or are under treatment for any such condition which, in the opinion of the Investigator, may constitute an unwarranted risk or which may affect the subjects' compliance or adherence to study procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153071


Locations
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United States, Texas
Westlake Dermatology Clinical Research Center
Austin, Texas, United States, 78746
Sponsors and Collaborators
Alma Lasers
Investigators
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Principal Investigator: Daniel Friedmann, MD, FAAD Westlake Dermatology Clinical Research Center
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Responsible Party: Alma Lasers
ClinicalTrials.gov Identifier: NCT04153071    
Other Study ID Numbers: ALM-OPUS-19-010
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes